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| Name | Class |
|---|---|
| Eisai Co., Ltd. | INDUSTRY |
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The primary objective of this study is to evaluate the absolute bioavailability of a single, fixed subcutaneous (SC) dose of aducanumab compared with a single weight-based intravenous (IV) dose of aducanumab in healthy volunteers.
The secondary objectives of this study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional pharmacokinetic (PK) parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose of aducanumab in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aducanumab Intravenous | Experimental | Participants will receive aducanumab as body weight-based dose, via IV infusion for approximately 1 hour on Day 1. |
|
| Aducanumab Subcutaneous | Experimental | Participants will receive aducanumab as fixed dose, via SC injection on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aducanumab | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Aducanumab | Up to Day 85 | |
| Maximum Observed Concentration (Cmax) of Aducanumab | Up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Qps-Mra, Llc |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| ID | Term |
|---|---|
| C000600266 | aducanumab |
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| Up to Day 85 |
| Number of Participants with Clinically Significant Abnormalities in Vital Signs | Up to Day 85 |
| Number of Participants with Clinically Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) | Up to Day 85 |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Assessments | Up to Day 85 |
| Area Under the Concentration-Time Curve from Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab | Up to Day 85 |
| Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC | Up to Day 85 |
| Elimination Half-Life (t½) of Aducanumab | Up to Day 85 |
| Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab | Up to Day 85 |
| Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab | Up to Day 85 |
| South Miami |
| Florida |
| 33143 |
| United States |